Orange Book product · Brand (NDA)
DOBUTREX
DOBUTAMINE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
DOBUTAMINE HYDROCHLORIDE
Strength
EQ 12.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 017820
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1993DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%Brand (NDA)
NDA 020269 · HOSPIRA
- 1993DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 020255 · BAXTER HLTHCARE
- 1993DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 020201 · HOSPIRA
- 2022DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216131 · SLATE RUN PHARMA
- 1998DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074545 · LUITPOLD
- 1998DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074995 · DR REDDYS
- 1998DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074279 · WATSON LABS INC
- 1996DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074634 · HOSPIRA
- 1996DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074381 · BAXTER HLTHCARE
- 1995DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074098 · TELIGENT
- 1995DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074292 · HOSPIRA
- 1994DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074277 · HIKMA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
